T 0649/20 - Exact publication date unnecessary

Key points

•  " The patent in suit claims priority from a US patent application filed on 25 May 2006. Document D1 is a scientific article which was published in 2006 in volume 102 of the journal Anesthesia & Analgesia. The exact publication date of D1 is not available in the document itself. As evidence for its publication date being before the priority date of the patent, the respondent provided the following documents during the opposition proceedings: D1a, D14, D15 and D16."
• The board reviews the submitted evidence.
• "the board concludes that, although D1 does not feature any publication date other than the year of 2006, there is evidence on file indicating that the issue to which D1 belongs has the date of 1 May 2006 (D1a) and that it had been published on 21 April 2006 (D15 and D16). Moreover, there is evidence that the printed edition of the journal issue was publicly available on 19 May 2022, as this was the date of receipt at one public library (D14). There is no evidence on file contradicting this evidence."
• " The board is not persuaded by the appellant's arguments that the evidence on file is contradictory and does not make it possible to clearly establish when D1 was published. The fact that both a senior managing editor and a senior publisher of the journal independently indicate the same date as the date of publication for the issue in question makes it possible to conclude with a high degree of certainty that this is the correct publication date. The board fails to see any good reason to doubt the credibility of Ms [L] and Mr [B] , and the appellant has not provided any evidence to support such allegations. Moreover, it is sufficient to establish that the document was available to the public before the priority date in order to conclude that it is prior art. D14 is already considered to provide sufficient evidence that D1 was in fact publicly available before the priority date. Contrary to the appellant's arguments, it is not relevant whether or not a member of the public indeed had access to it; the librarian that received the issue and registered it in the database from which D14 has been obtained is a member of the public in any case for the purposes of Article 54(2) EPC (see e.g. T 834/09, points 5.1 to 6.3 of the Reasons)."

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/law-practice/case-law-appeals/recent/t200649eu1.html

4. Status of D1 as prior art

4.1 The patent in suit claims priority from a US patent application filed on 25 May 2006. Document D1 is a scientific article which was published in 2006 in volume 102 of the journal Anesthesia & Analgesia. The exact publication date of D1 is not available in the document itself. As evidence for its publication date being before the priority date of the patent, the respondent provided the following documents during the opposition proceedings: D1a, D14, D15 and D16.

4.2 D1a is a printout of an online entry entitled "Archive of 2006 Online Issues". The web address is "http://www.anesthesia-analgesia.org/content/by/year/2006". The document lists all 12 monthly issues of the journal. It is apparent that volume 102 includes the May issue, for which the following information is given: "May 1; 102(5): 1304-1600". The May issue was actually the last one of the issues belonging to volume 102 and in view of the page numbers covered by this issue, it clearly included the article corresponding to D1 (pages 1316-1319).

4.3 In addition, D14 is an extract from the public database from the Central Library for Medicine of the Leibniz Life Sciences Information Center (Zentralbibliothek für Medizin des Leibniz-Informationszentrum Lebenswissenschaften), wherein the dates of receipt of subscribed journal issues are listed, i.e. the journal Anesthesia & Analgesia in the present case. On page 4 of the extract, it can be seen that the May 2006 issue of volume 102 of the journal (labelled in D14 as "102.2006,5") was received twice ("2x") by the library on 19 May 2006.

4.4 Finally, documents D15 and D16 are two printouts of email exchanges between the respondent's professional representative Mr Stephan Tatzel and Ms Nancy Lynly (D15) and Mr Kivmars Bowling (D16). The email exchanges consist of enquiries by the above-mentioned professional representative on the publication date of the May 2006, volume 102 issue of the Anesthesia & Analgesia journal and the respective replies by Ms Lynly, Senior Managing Editor at "Anesthesia & Analgesia", and Mr Bowling, Senior Publisher in the department of Health Learning, Research & Practice at Wolters Kluwer (publisher of the Anesthesia & Analgesia journal). Both Ms Lynly and Mr Bowling indicate the same date, 21 April 2006, as the "official date for public availability of the May 2006 issue" (Ms Lynly) and as the date when the "article went live" (Mr Bowling).

4.5 Accordingly, the board concludes that, although D1 does not feature any publication date other than the year of 2006, there is evidence on file indicating that the issue to which D1 belongs has the date of 1 May 2006 (D1a) and that it had been published on 21 April 2006 (D15 and D16). Moreover, there is evidence that the printed edition of the journal issue was publicly available on 19 May 2022, as this was the date of receipt at one public library (D14). There is no evidence on file contradicting this evidence.

4.6 The board is not persuaded by the appellant's arguments that the evidence on file is contradictory and does not make it possible to clearly establish when D1 was published. The fact that both a senior managing editor and a senior publisher of the journal independently indicate the same date as the date of publication for the issue in question makes it possible to conclude with a high degree of certainty that this is the correct publication date. The board fails to see any good reason to doubt the credibility of Ms Lynly and Mr Bowling, and the appellant has not provided any evidence to support such allegations. Moreover, it is sufficient to establish that the document was available to the public before the priority date in order to conclude that it is prior art. D14 is already considered to provide sufficient evidence that D1 was in fact publicly available before the priority date. Contrary to the appellant's arguments, it is not relevant whether or not a member of the public indeed had access to it; the librarian that received the issue and registered it in the database from which D14 has been obtained is a member of the public in any case for the purposes of Article 54(2) EPC (see e.g. T 834/09, points 5.1 to 6.3 of the Reasons).

4.7 Document D1 is thus prior art pursuant to Article 54(2) EPC for the claimed subject-matter.

5. Main request, novelty

5.1 Document D1 discloses the measurement of patients' bivalirudin levels by a thrombelastograph ecarin clotting time assay (TEG® ECT); see e.g. the title. It is not disputed that such an assay is used to determine a "clot strength related quantitative indication of a (...) blood sample hemostasis characteristic" as defined in the claim; this is also the assay that is used in the patent (e.g. paragraphs [0027] and [0029]). D1 explicitly states that "The reaction time until detectable clot formation (R) was chosen as the comparative parameter" (page 1318, left-hand column, lines 4 to 6), which is also a feature of the claim. Moreover, D1 discloses measurements of said hemostasis parameters both before and after anti-coagulation hemostasis therapy (see Figures 1 and 2 of D1), as also required in the claim. Finally, D1 discusses Figure 2 as follows (page 1318, right-hand column, lines 1 to 5): "A typical set of patient TEG® tracings before and after bivalirudin treatment is shown in Figure 2. The R value shows the greatest change in response to bivalirudin with smaller reductions in time after the R point ...". The board thus agrees with the opposition division's conclusions and the respondent's arguments that D1 does disclose the method step of determining a parameter indicative of the efficacy of the anti-coagulation therapy based upon the first and the second quantitative indication.

5.2 For the above reasons, the board disagrees with the appellant's arguments that the feature "determining a parameter indicative of the efficacy of the anti-coagulation hemostasis therapy based upon the first and the second quantitative indications, the second quantitative indication demonstrating a contribution to clot formation delay in comparison to the first quantitative indication" is not directly and unambiguously disclosed in D1, because such a parameter was not implicitly, let alone explicitly, disclosed in D1. As explained above, said parameter is indeed at least implicitly disclosed in D1, even if it is not defined in the same way as in the claim. As argued by the respondent, the passages in D1 disclosing said feature (Figure 1 and page 1318, right-hand column, first paragraph) correspond to the disclosure in the patent in paragraph [0064] and Figures 14a and 14b, which are the passages on which the appellant relies in the context of sufficiency of disclosure (appellant's letter of 7 December 2020, page 3, first paragraph of section 4.2).

5.3 Claim 1 of the main request thus lacks novelty over D1 (Article 54(2) EPC).